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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979-01-17 - 1979-05-03
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
However, limited details were provided on exposure conditions (i.e., particle size determination), test substance (i.e., purity), and animal husbandry. Only one concentration was used and exposure was for 8 hours without a justification provided.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
Limited details were provided on exposure conditions (i.e., particle size determination), test substance (i.e., purity), and animal husbandry. Only one concentration was used and exposure was for 8 hours without a justification provided.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Physical state: liquid
- Storage condition of test material: Room temperature
Specific details on test material used for the study:
- Name as cited in study report: Poly[oxy(methyl-1,2-ethanediyl)], alpha-(2-aminomethylethyl)-omega-(2-aminomethylethoxy)
- Substance type: active
- Color: clear, amber
- Lot: Jefferson chemical company, sample no. AVS-0381, 4236-10-20a, SPC no. 1575

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, Massachusetts
- Weight at study initiation: 209-254
- Other: The animals were observed prior to exposure to assure that they were free from abnormalities.


IN-LIFE DATES: From: 1979-01-17 To: 1979-01-31

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Remarks:
dry
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: A glass exposure chamber housed the animals.
- Exposure chamber volume: 26.5 liter
- Source and rate of air: 4.0 liters per minute
- Method of conditioning air: The test substance was placed in a 500 milliliter gas-washing bottle. Dry air, at the minimum chamber flow rate of 4.0 liters per minute, was passed through the test substance and the resultant vapor-laden air was directed, undiluted, into the exposure chamber housing the test animals.
- Temperature, humidity, pressure in air chamber: the chamber temperature during the exposure was 22 degrees C.
- Other: The flask containing the test substance, two glass tubes, and connectors were weighed before and after the exposure period. The difference in weight was equal to the amount of test substance volatilized during the exposure. The nominal concentration was calculated by dividing the weight loss by the total air flow through the chamber during the exposure period.



Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
ca. 8 h
Concentrations:
0.74 mg/L (1.42 grams of test substance delivered in a total volume of 1920 liters of dry air)
No. of animals per sex per dose:
5 animals per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for abnormal signs were recorded at 15 minute intervals for the first hour of exposure, hourly for the remaining seven hours of the exposure, upon removal from the chamber, at one hour post-exposure, and daily thereafter for 14 days. Individual body weights were recorded on day 0 (prior to exposure) and on Days 1, 2, 4, 7 and 14 (terminus) for all animals.
- Necropsy of survivors performed: yes; On Day 14 all animals were sacrificed (ethyl ether) and gross necropsy examinations were performed.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.74 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: No mortality was observed at 0.74 mg/L
Mortality:
No mortalities occurred.
Clinical signs:
other: No abnormalities were observed in any animals during the exposure. Upon removal from the chamber, one animal was observed to have dry rales. At one-hour post-exposure dry rales was noted again in the same animal. During the 14-day observation period dr
Body weight:
Individual body weight data showed normal weight gains in all animals except one male, which showed a somewhat depressed weight gain pattern.
Gross pathology:
Necropsy examinations revealed lung discoloration in nine of ten animals and kidney discoloration in six of ten animals. The frequency of lung and kidney discoloration was higher than that normally observed in Sprague-Dawley rats in this type of exposure and may have been indicative of a response to the exposure.

Applicant's summary and conclusion

Interpretation of results:
other: not enough data to determine classification; only tested one dose level
Conclusions:
The acute inhalation toxicity of the test substance was evaluated in male and female rats. The LC50 was determined to be >0.74 mg/L.